PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
How to Trial a Device in a VCH Facility
Gordon McConnell, P. Eng.
Vancouver Coastal Health Authority
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
R K MANAGEMENT
RIS
HR
CREB VCHRI
BME
OPERATING ROOMS
SSD
INFECTION CONTROL
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
The Medical Device Development Safety Committee
(Th Reprocessing
(The
R
i Variance
V i
Committee)
C
itt )
Committee
Risk Management (Medical Affairs)
Infection Control
Medical Device Reprocessing Department (MDRD)
Biomedical Engineering
Operating Rooms
Diagnostic Imaging
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
YES
Research?
NO
CREB
VCHRI
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
CREB – Clinical Research Ethics Board
VCHRI – Vancouver Coastal Health Research Institute
All research studies involving human
subjects that utilize VCH property,
resources, facilities, patients or staff, must
receive VCH approval to conduct
research in addition to ethical approval
approval.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
GUIDELINE FOR OBTAINING APPROVAL TO CONDUCT RESEARCH
AT VANCOUVER COASTAL HEALTH
http://www.vchri.ca/
DEFINITION OF RESEARCH
A research study … will be considered … as being research involving human
subjects if:
• A human is subjected to procedures, the purpose of which go beyond the
subject’s need for prophylaxis, diagnosis or therapy; or
• A human
h
iis subjected
bj
d to procedures
d
which
hi h are experimental
i
lb
but which
hi h d
do
not necessarily go beyond the subject’s need for prophylaxis, diagnosis, or
therapy; or
• Procedures are used in which an invasion of privacy may be involved, for
example, by examination of records, by interviews, by observations, by
administration of a questionnaire or test, or by audio or video recording; or
• Human tissue, biological fluids, embryos or fetuses are being studied.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
GUIDANCE: WHEN DOES YOUR PROJECT
WARRANT REVIEW BY A RESEARCH ETHICS
BOARD? http://www.vchri.ca/
http://www vchri ca/
Does your project warrant review by a research
ethics
thi board?
b
d?
1. …
2. …
3 Does the project involve the use of a medical device … which
3.
requires approval from Health Canada …
4. …
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Examples of Non-Research Devices:
Shuttle
Reusable Blanket for a Forced-Air Patient Warmer
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Shuttle
Forced-Air Patient Warmer
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
YES
Research?
NO
CREB
VCHRI
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
HEALTH CANADA
Food and Drugs Act
Medical Device Regulations
Is the item a medical device?
If so, what
h t is
i its
it class?
l
?
Does it have a medical device licence?
Does the use of the device constitute a “sale”?
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
The Definition
Th
D fi iti off a M
Medical
di l D
Device
i under
d th
the Food
F d and
d
Drugs Act
The Food and Drugs Act (1) defines a "device" as any article, instrument,
apparatus or contrivance, including any component, part of accessory thereof,
manufactured, sold or represented for use in:
the diagnosis,
diagnosis treatment
treatment, mitigation or prevention of a disease,
disease disorder or
abnormal physical state;
restoring, correcting or modifying a body function or the body structure;
the diagnosis of pregnancy; or
care during pregnancy and at and after birth.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
M di l D
Medical
Device
i Cl
Classification:
ifi ti
…
Medical devices are classified into one of Classes I to IV by
means of the classification rules … where Class I represents
the lowest risk and Class IV represents the highest risk.
…
… no person shall import or sell a Class II, III or IV medical
device unless the manufacturer of the device holds a licence in
respect of that device …
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Keyword Index to Assist Manufacturers in
Verifying the Class of Medical Devices:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbhtt
//
h
/dh
/ lt f
t /h fb
dgpsa/pdf/md-im/keyword_motscles2-eng.pdf
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Medical Device Licence
http://www.hc
http://www
hc-sc
sc.gc.ca/dhp
gc ca/dhp-mps/md-im/licen/mdlicmps/md im/licen/mdlic
eng.php
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Medical Devices Regulations
http://laws-lois.justice.gc.ca/eng/regulations/
…
These Regulations apply to
(a) the sale and advertising for sale of a medical device; and
(b) the importation of a medical device for sale or for use on
i di id l other
individuals,
th th
than iimportation
t ti ffor personall use.
Therefore, if the medical device “belongs to” VCH and there is
no
o “sale”
sa e o
or “importation”
po tat o involved
o ed with
t it,
t, tthe
e MDR do not
ot
apply.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Medical Devices Regulations
● PART 1 GENERAL
Device has a medical device licence if Class 2, 3, or 4.
● PART 2 CUSTOM-MADE DEVICES AND MEDICAL
DEVICES TO BE IMPORTED OR SOLD FOR SPECIAL
ACCESS
(1) This Part applies to custom-made devices and medical devices
that are to be imported
p
or sold for special
p
access.
(2) In this Part, “special access” means access to a medical device
for emergency use or if conventional therapies have failed, are
unavailable or are unsuitable
● PART 3 MEDICAL DEVICES FOR INVESTIGATIONAL
TESTING INVOLVING HUMAN SUBJECTS
This Part applies to medical devices that are to be imported or sold
for investigational testing involving human subjects
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Medical Device Regulations
The medical device that I mentioned is … . The researchers have done
substantial bench testing and would now like to test the device in
parallel with the conventional means … to validate the technique and to
gather data to help with the design of the device. The research
proposal was submitted to the Clinical Research Ethics Board and
given provisional approval pending contact with Health Canada
regarding licensing.
The principle investigator is an orthopedic surgeon on staff at
Vancouver General Hospital, and the device is being developed in
conjunction with a medical engineering professor and a graduate
student at the University of British Columbia as a Master of Applied
Science project.
My question to you is whether the device requires a license given that it
is custom built for use at VGH, and at this point, is being evaluated only
for "proof of principle" which precedes any thought of commercialization
(i.e., sale or distribution) of the product.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Medical Device Regulations
…
We have looked at the scenario below and if according to the
definition of sell in the Food and Drugs Act, this product is not being
sold or distributed to a party outside of the hospital then the product
would not need to have a medical device licence.
If however you wish to distribute to other hospitals, then you would
need to obtain a medical device licence for the product.
Sincerely,
Nancy Shadeed
Head, Regulatory and Scientific Section
Device Licensing Division
Medical Devices Bureau
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
YES
Research?
NO
CREB
VCHRI
Biomedical Engineering and Medical Device Reprocessing Committee
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Process Flow
Chart
(Beadon Protocol)
Dose
Mapping
Start
Maximum Dose
Determination
Minimum Dose
Determination
Permission from the OR
Mechanical
Safety Tests
Electrical
Safety Tests
Proposed
Sterilization
Method
Sterilization
Validation
MDDSC
Biomedical Engineering and
Reprocessing Variance Committee
Additional
D i andd
Design
Function
Information
CREB
Application
MDDSC Variance Committee
Biomedical Engineering and Reprocessing
Approval to
Proceed
Approval
Application for
VCHRI
Approval
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Electrical Testing
The VCHA Biomedical Engineering Department
assures the device has the necessary approvals
evaluates the device to assure it is safe to use in
the proposed research
inspects the device using in-house inspection
procedures
Inspection Procedure:
General Device
Vancouver Coastal Health Authority
Biomedical Engineering Department
G25
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
M h i lT
Mechanical
Testing
ti
The VCHA Biomedical Engineering Department
evaluates the device to assure it is safe to use in
the proposed research
assures that the device remains intact and
functional after exposure to the environment and the
stresses that it will experience throughout sterilization
and use cycles.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Sterilization Method
See “Guidance concerning sterilization instructions for research devices for use on humans” at
http://vchconnect.vch.ca/programs_services/client_relations/reprocessing_of_medical_devices/reprocessin
g_variance_cmtee/page_78970.htm
The necessaryy level of sterilization ((or disinfection)) is determined
(Spaulding’s Classification of Medical Equipment and Required Level
of Processing).
The method of sterilization is chosen ((MoH Guidelines for the
Cleaning Disinfection and Sterilization of Medical Devices in Health
Authorities).
Ap
plan for the validation of the sterilization method is chosen. The
validation tests are minimum dose determination, maximum dose
determination and, when radiation is used, dose mapping.
p
g Variance Committee may
y require
q
a sterilization
The Reprocessing
challenge.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Mi i
Minimum
D
Dose D
Determination
i i
The minimum sterilization dose necessary to
ensure sterility must be determined.
A sterilization facility will sterilize samples at
different doses.
These
Th
sterilized
t ili d samples
l sentt tto a microbiology
i bi l
lab for sterility testing.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
D
Dose
M
Mapping
i
Devices that will be sterilized using irradiation
techniques must undergo a dose-mapping procedure.
Dose mapping is the determination of the zones of
minimum
i i
and
d maximum
i
d
dose iin th
the d
device
i package
k
b
by
placing dosimeters at strategic locations.
This p
process allows for the dose being
g applied
pp
at
various areas of the device to be correlated to the dose
measured at a position outside the device packaging.
This is necessary to ensure that the minimum dose
is applied to the entire device.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
M i
Maximum
D
Dose D
Determination
i i
Testing is done to assure the function of the device
is not compromised when the device is sterilized.
The
Th function
f
ti and
d safety
f t off a single-use
i l
d i iis
device
verified after sterilization with a dose that is greater
than what would normally be used.
Re-usable devices are tested after being subjected
to a dose in excess of the total dose that can be
applied to the device based on the number of
reprocessing cycles allowed.
allowed
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
S ili i Ch
Sterilization
Challenge
ll
A sterilization challenge test may be needed if the device is
likelyy to be difficult to sterilize.
The sterilization challenge involves inoculating the device
with a known concentration of organisms, processing it with
the prescribed cleaning and sterilization technique
technique, and then
performing the aforementioned sterility tests.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Use of Non-Medical Devices in Patient Care
Areas and the Patient Care Environment
CSA Z32: Electrical safety and essential electrical systems in health care facilities
Patient Care Area: An area intended primarily for diagnosis,
therapy, or care.
Patient Care Environment: A Zone … that has been
preselected for the accommodation of a patient bed … and …
equipment involved in patient treatment … which includes
space within the room 1.5 m beyond the perimeter of the bed
… and to within 2
2.3
3 m of the floor
floor.
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Use of Non-Medical Devices in Patient Care
A
Areas
and
d th
the P
Patient
ti t C
Care E
Environment
i
t
CSA Z32: Electrical safety and essential electrical systems in health care facilities
4.3.4 Non –medial electrical equipment used in patient care areas
4.3.4.1 General
The HCF’s
Th
HCF’ nonmedical
di l electrical
l t i l equipment
i
t shall
h ll be
b approved
d … to
t the
th
applicable Standard and shall be covered by the HCF’s electrical safety
program.
4.3.4.2 Patient environment requirements
… non-medical electrical equipment to be used in the patient care
environment shall
(a)be battery powered and less than 30 V;
(b)be limited to extra-low-voltage
extra low voltage Class 2 circuits; or
(c)have a leakage current, chassis to ground, of less that 500 µA
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Use of Non-Medical Devices in Patient Care
Areas and the Patient Care Environment
CAN/CSA-C22.2 NO. 60601-1-1-02 (R06) - Medical Electrical Equipment - Part 11: General Requirements for Safety - Collateral Standard: Safety Requirements
for Medical Electrical Systems
Annex I (informative) ME system aspects
I.1 Combinations of ME Equipment and non-ME Equipment
I.1.1 … This annex provides a summary of situations that could occur when
different combinations of equipment are used in various medical environments. …
I.1.2 Localities in a medical environment
The following localities are foreseen
The p
patient environment as p
part of a medically
y used room
A medically used room, excluding the patient environment
The non-medically used room …
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES
Acknowledgements
Katherine Beadon, B.Sc. (Physics), MASc
g
g
UBC Mechanical Engineering
Antony Hodgson, PhD, PEng
Professor & NSERC Chair in Design Engineering
UBC Mechanical Engineering
Biomedical
o ed ca Engineering
g ee g
[email protected]